Two compounding pharmacies start voluntary recall of sterile drugs

FDA says drugs produced under conditions that could lead to contamination

SILVER SPRING, Md. — Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

The Food and Drug Administration said Tuesday that ApotheCure had recalled all sterile drug products made at its pharmacy, while NuVision Pharmacy had recalled sterile freeze-dried or lyophilized drug products made at its facility. Both recalls were described as voluntary.

The FDA said pharmacies, hospitals and other healthcare facilities that have received the products should keep them quarantined until receiving further instructions from ApotheCure and NuVision. The agency said the warning was based on inspections of the two companies' pharmacies.

In a blog post last week, FDA commissioner Margaret Hamburg said that inspections of 31 pharmacies that did sterile compounding found a variety of sanitation problems ranging from mold and rust in clean rooms to staff members handling sterile drugs with their bare hands in all but one of them. Neither ApotheCure nor NuVision was named in the report.